The Development of a System for Measurement of Tremor

The goal of this clinical trial is to develop a system which can be used to measure movements in people with Essential Tremor (with or without dystonia).

The main questions it aims to answer are:

• Can individuals with Essential Tremor be distinguished from individuals without tremor using Virtual Reality (VR)
• Can the current Essential Tremor Assessment Scale (the TETRAS) be reproduced in VR
• Can Essential Tremor be quantified using a measurement system
• Can Dystonia be quantified using a measurement system. Participants will don the equipment used to measure their tremor and replicate a series of standardized movements to measure their tremor, in and out of the VR platform. The assessment will take no longer than an hour.

Study Overview

• Status: Completed
• Conditions: Dystonia; Essential Tremor
• Intervention / Treatment: Device: Virtual Reality measurement of essential tremor and dystonia

Detailed Description

This study aims to develop a way of objectively measuring the neurological disorders, Essential Tremor (ET) and dystonia. These conditions can affect the upper and lower limbs, head, voice, face and trunk. ET and dystonia can be difficult to assess and treat, particularly if severe, and therapies are limited.

Currently the severity of these conditions is formally assessed by clinician rated scales such as the Essential Tremor Rating Assessment Scale (TETRAS) which is biased towards the upper limbs, requires training and is not objective. There is a need for a more precise, less variable measure of tremor that can used easily be non-expert clinicians. This study questions whether it is possible to quantify ET and dystonia using a measurement system in a virtual reality (VR) environment.

Data will be collected from measurement sensors embedded in the VR environment from healthy control participants, and those with ET with and without dystonia. Participants will be placed in a VR environment and instructed to perform the TETRAS. This will help to develop an algorithm which can measure ET severity using machine learning. It is expected that the algorithm will provide a better assessment of ET and dystonia than the TETRAS. This study may pave the way towards the development of simpler devices to which the algorithm can be applied.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • The Royal Victorian Eye and Ear Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria - Control participants

• Aged 18 to 80 years
• Able to provide informed consent for self
• Able to comply with all study procedures

Exclusion Criteria -Control participants

• Any neurological disorder
• Any other non-neurological cause of tremor e.g. medication induced

Inclusion Criteria - ET participants

• Aged 18 to 80 years
• Able to provide informed consent for self
• Clinical diagnosis of ET or ET plus syndrome
• Able to comply with all study procedures

Exclusion Criteria - ET Participants

• Tremor other than ET (e.g. parkinsonian, functional tremor)
• Presence of other movement disorder
• For Deep Brain Stimulation (DBS) participants: unwilling or unable to turn off and on their own stimulator for the duration of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Experimental: Virtual Reality & Movement Monitoring; Participants will don the equipment used to measure their tremor and replicate a series of standardized movements to measure their tremor, in and out of the VR platform.

Device: Virtual Reality measurement of essential tremor and dystonia; The virtual reality (VR) platform, which detects whole-of-body movements. The VR environment is a series of sensors in a room that detect whole body motion and a series of sensors worn by the participant. As well the participant dons VR "goggles" that allows them to "see" a virtual environment in which they can perform the TETRAS.Within the VR platform, an avatar (an electronic image that represents the participant) is produced in the VR environment, and this will be used to review the participant.; Sensors for the detection of wrist, head and voice tremor. The sensors are small devices worn on the wrists and head of the participant and are similar to those used in the VR system. A microphone is attached to the participants to detect voice tremor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. To quantify Essential Tremor and dystonia using a measurement system	Using commercially available Virtual Reality (VR) equipment and a commercially available Inertial Measurement Unit (IMU), the presence of the tremor and dystonia in participants with Essential Tremor will be measured and their severity rated.	At enrolment. This study is a single assessment conducted at one time point.

Collaborators and Investigators

• Sponsor: The Bionics Institute of Australia
• Collaborators: The Florey Institute of Neuroscience and Mental Health
• Investigators: Principal Investigator: David Szmulewicz, MBBS PhD, The Royal Victorian Eye and Ear Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2023
• Primary Completion (Actual): November 20, 2024
• Study Completion (Actual): November 20, 2024

Study Registration Dates

• First Submitted: May 22, 2023
• First Submitted That Met QC Criteria: July 13, 2023
• First Posted (Actual): July 21, 2023

Study Record Updates

• Last Update Posted (Actual): April 20, 2025
• Last Update Submitted That Met QC Criteria: April 16, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Virtual Reality; Essential Tremor; Dystonia; Biokin
• Additional Relevant MeSH Terms: Neurologic Manifestations; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Dyskinesias; Tremor; Dystonia; Dystonic Disorders; Essential Tremor
• Other Study ID Numbers: 23-1562H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: None. No findings of direct clinical relevance are expected.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No